On November 1, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the third quarter ended September 30, 2022 (Press release, Acorda Therapeutics, NOV 1, 2022, View Source [SID1234622697]).
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"The AMPYRA arbitration ruling was a major milestone for Acorda, providing a significant cash infusion and, even more importantly, the ability for us to obtain AMPYRA supply at far more competitive rates. We expect this to significantly enhance the value of this product to the company," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We are also pleased that INBRIJA continued to recover from the impact of the pandemic surge in the first quarter of this year. Independent sources show that INBRIJA is the market leader for on-demand treatments in Parkinson’s disease, with a 67% share. Our highest priority now is to increase the size of the overall on-demand market by educating health care professionals and people with Parkinson’s about how important it is to address OFF periods."
Regarding the Special Meeting of Stockholders, Dr. Cohen added, "The board of directors and I urge all shareholders to vote FOR Proposal 2, to authorize the reverse stock split, in advance of the meeting on November 4. This is critical to ensure that we are not de-listed from Nasdaq, which could hamper our ability to execute on our business plan and could result in our being in default to our debtholders."
Third Quarter 2022 Financial Results
For the quarter ended September 30, 2022, the Company reported INBRIJA worldwide net revenue of $8.8 million, of which $7.8 million was derived from sales in the U.S., a 1% increase compared to the same quarter in 2021. The Company also reported Ex-U.S. INBRIJA net revenue of $1.0 million in the third quarter related to the Esteve launch in Germany.
For the quarter ended September 30, 2022, the Company reported AMPYRA net revenue of $21.1 million, compared to $20.0 million for the same quarter in 2021. As previously disclosed, AMPYRA lost its exclusivity and generics entered the market in 2018, and the Company expects AMPYRA revenue to continue to decline.
Research and development (R&D) expenses for the quarter ended September 30, 2022 were $1.4 million, including negligible share-based compensation expenses, compared to $1.9 million, including $0.2 million of share-based compensation for the same quarter in 2021.
Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2022 were $23.0 million, including $0.4 million of share-based compensation, compared to $29.6 million, including $0.6 million of share-based compensation for the same quarter in 2021.
Change in fair value of derivative liability for the quarter ended September 30, 2022 was negligible, compared to $(0.3) million for the same quarter in 2021.
Provision for income taxes for the quarter ended September 30, 2022 was $1.4 million, compared to a benefit from income taxes of $3.1 million for the same quarter in 2021.
The Company reported a GAAP net loss of $13.9 million for the quarter ended September 30, 2022, or $0.57 per diluted share. GAAP net loss in the same quarter of 2021 was $27.1 million, or $2.43 per diluted share.
Non-GAAP net loss for the quarter ended September 30, 2022 was $13.3 million, or $0.55 per diluted share. Non-GAAP net loss in the same quarter of 2021 was $15.9 million, or $1.43 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, changes in the fair value of derivative liability related to our 2024 convertible senior secured notes, and expenses that pertain to non-routine corporate restructurings. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.
At September 30, 2022, the Company had cash, cash equivalents, and restricted cash of $34.2 million, compared to $65.2 million at year end 2021. Restricted cash includes $12.4 million in escrow related to the semi-annual interest payment to the holders of its 6.00% convertible senior secured notes (Convertible Notes). Cash at September 30, 2022 does not include the $16.5 million arbitration award, which amount was received in October 2022
Special Meeting of Stockholders November 4, 2022
Acorda will hold a Special Meeting of Stockholders on Friday, November 4 (the Special Meeting). Acorda’s CEO, board and the three leading proxy advisory firms recommend that shareholders vote FOR both of the following proposals to be addressed at the meeting:
Reverse Stock Split Proposal: To authorize Acorda’s Board of Directors to implement a reverse stock split of its common stock at a ratio of any whole number in the range of 1-for-2 to 1-for-20 within one year of the Special Meeting. This proposal is critical to get Acorda’s stock price above $1.00 per share in order to avoid being delisted from Nasdaq. Delisting could put the company in default to the holders of its Convertible Notes, potentially requiring Acorda to liquidate or file for bankruptcy. In a reverse stock split, shareholders would hold the exact same percentage of Acorda stock, with the same value as they did prior to the split.
Adjournment Proposal: To approve one or more adjournments of the Special Meeting to a later date or dates, if necessary or appropriate, to solicit additional proxies if there are insufficient votes to approve the Reverse Stock Split Proposal at the time of the Special Meeting, or in the absence of a quorum.
AMPYRA Arbitration
On October 16, 2022 we announced that an arbitration panel issued a final decision in a dispute with Alkermes PLC (Nasdaq: ALKS) regarding licensing royalties relating to AMPYRA (dalfampridine). Acorda was awarded $15 million plus prejudgment interest of $1.5 million from Alkermes. In addition, as a result of the panel’s ruling, Acorda will no longer have to pay Alkermes any royalties on net sales for license and supply of AMPYRA, and Acorda is now free to use alternative sources for supply of AMPYRA, which it has already secured.
2022 – 2027 Financial Guidance
For the full year 2022, Acorda continues to expect AMPYRA net revenue to be $68 – $78 million, and adjusted operating expenses to be $110 – $120 million. The financial guidance provided below includes non-GAAP projections of adjusted operating expenses (adjusted OPEX) and adjusted earnings before income taxes depreciation and amortization (adjusted EBITDA), as described below under "Non-GAAP Financial Measures."